MAV · Class II · 21 CFR 870.1650

FDA Product Code MAV: Syringe, Balloon Inflation

Leading manufacturers include Boston Scientific Corp, C.R. Bard, Inc. and Medtronic Vascular.

57
Total
57
Cleared
120d
Avg days
1981
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Syringe, Balloon Inflation Devices (Product Code MAV)

57 devices
1–24 of 57
Cleared Apr 13, 2022
Everest 20 Inflation Device and 3-way Stopcock (AC2200)
K220773
Medtronic Vascular
Cardiovascular · 28d
Cleared Jan 12, 2015
Presto Inflation Device
K143522
C.R. Bard, Inc.
Cardiovascular · 31d
Cleared Apr 17, 2014
ENCORE 26 ADVANTAGE KIT
K140745
Boston Scientific Corp
Cardiovascular · 23d
Cleared Nov 13, 2012
ENCORE 26 ADVANTAGE KIT
K123214
Boston Scientific Corp
Cardiovascular · 29d
Cleared Apr 03, 2012
ENCORE 26 ADVANTAGE KIT
K120694
Boston Scientific Corp
Cardiovascular · 27d
Cleared Dec 08, 1992
10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE
K922573
Boston Scientific Corp
Cardiovascular · 190d
Cleared Sep 16, 1991
CORDIS INFLATOR DEVICE
K912644
Cordis Corp.
Cardiovascular · 91d
Cleared Dec 03, 1990
INFLATION/DEFLATION DEVICE
K904394
Boston Scientific Corp
Cardiovascular · 69d
Cleared Dec 20, 1989
INFLATION PRO II
K895836
Baxter Healthcare Corp
Cardiovascular · 78d

About Product Code MAV - Regulatory Context

510(k) Submission Activity

57 total 510(k) submissions under product code MAV since 1981, with 57 receiving FDA clearance (average review time: 120 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.